Technetium Tc-99m Exametazime And Cobaltous Chloride
Generic Name: technetium tc-99m exametazime and cobaltous chloride
Brand Names:
Ceretec
11 DESCRIPTION 11.1 Chemical Characteristics Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitroge...
Overview
11 DESCRIPTION 11.1 Chemical Characteristics Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitroge...
Uses
1 INDICATIONS AND USAGE Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 1.1 Leukocyte Labeled Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease.
Dosage
2 DOSAGE AND ADMINISTRATION Do not use cobalt stabilizer solution for leukocyte labeled scintigraphy. ( 2.1 ) Use appropriate radiation safety measures and aseptic technique during preparation and handling. ( 2.1 ) Leukocyte Labeled Scintigraphy - The recommended adult dose is 185 MBq to 370 MBq (5 mCi to 10 mCi) of Tc 99m exametazime labeled leukocytes by intravenous injection. Administer as soon as possible after labeling, preferably within 20 minutes but no later than 1 hour. ( 2.2 ) Cerebral Scintigraphy - The recommended adult dose is 555 MBq to 1110 MBq (15 mCi to 30 mCi) by intravenous injection. ( 2.2 ) See full prescribing information for preparation and administration, interpretation of chromatograms and radiation dosimetry.
Side Effects
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. The following adverse reactions associated with the use of Ceretec were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Warnings
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been reported following the administration of Tc 99m exametazime injection and Tc 99m exametazime labeled leukocytes including serious signs and symptoms of anaphylaxis following administration [see Adverse Reactions (6) ] . Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. 4 CONTRAINDICATIONS None None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. Technetium Tc 99m exametazime is transferred across the placenta [see Data ]. Animal reproduction studies with technetium Tc 99m exametazime have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
Storage
16.2 Storage and Handling Store Ceretec kits at controlled room temperature 15°C to 25°C (59°F to 77°F). This reagent kit is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission or the relevant Agreement State. Store and dispose of technetium Tc 99m exametazime in compliance with the regulations of the government agency authorized to license the use of this radionuclide.
Frequently Asked Questions
What is Technetium Tc-99m Exametazime And Cobaltous Chloride used for?▼
1 INDICATIONS AND USAGE Ceretec is a radioactive diagnostic agent, indicated in adults and pediatric patients age 2 to 17 for: Leukocyte Labeled Scintigraphy – As an adjunct in the localization of intraabdominal infection and inflammatory bowel disease. ( 1.1 ) Cerebral Scintigraphy – As an adjunct in the detection of altered regional cerebral perfusion in stroke. ( 1.2 ) 1.1 Leukocyte Labeled Scintigraphy Ceretec, when reconstituted with technetium Tc 99m exametazime (without cobalt stabilizer solution), is indicated in adults and pediatric patients age 2 to 17 for leukocyte labeled scintigraphy as an adjunct in the localization of intraabdominal infection and inflammatory bowel disease.
What are the side effects of Technetium Tc-99m Exametazime And Cobaltous Chloride?▼
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1) ]. The following adverse reactions associated with the use of Ceretec were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Can I take Technetium Tc-99m Exametazime And Cobaltous Chloride during pregnancy?▼
8.1 Pregnancy Risk Summary Limited available data with technetium Tc 99m exametazime use in pregnant women are insufficient to inform any drug associated risks for major birth defects and miscarriage. Technetium Tc 99m exametazime is transferred across the placenta [see Data ]. Animal reproduction studies with technetium Tc 99m exametazime have not been conducted. However, all radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose.
What are the important warnings for Technetium Tc-99m Exametazime And Cobaltous Chloride?▼
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions ( 5.1 ) 5.1 Hypersensitivity Reactions Hypersensitivity reactions have been reported following the administration of Tc 99m exametazime injection and Tc 99m exametazime labeled leukocytes including serious signs and symptoms of anaphylaxis following administration [see Adverse Reactions (6) ] . Always have cardiopulmonary resuscitation equipment and personnel available and monitor all patients for hypersensitivity reactions. 4 CONTRAINDICATIONS None None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.